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Help for SME dossier submission still unclear, says EHPM

The European Food Safety Authority’s (EFSA) draft guidance for health claims dossiers has yet to clarify how it will ease the burden on SMEs, trade organisation EHPM has said.

The EFSA guidance document, which was published in May, outlines the requirements for the submission of article 14 dossiers – reduction of disease risk claims and claims referring to children's development and health. It aims to clarify what companies submitting health claims for authorisation should include in their application, particularly regarding scientific data and evidence.

But since the EU’s adoption of the Nutrition and Health Claims Regulation in December last year, concerns have been raised that food companies, particularly small and medium-sized enterprises (SMEs), would face financial and administrative difficulties complying with the regulation’s requirements.

“A lot of time has been spent discussing the feasibility of the Nutrition and Health Claims Regulation for SMEs,” said Peter van Doorn, Chairman of EHPM, “but these guidance notes are complex and potentially very expensive to comply with.”

According to EHPM, in the Regulation the legal basis for the guidance notes imposes upon the Commission and the Authority to make available the appropriate technical guidance and tools to assist food companies, in particular SMEs.

Mr Van Doorn said: “We consider it important that there is proper reflection to make sure that these guidelines are simple and easy to comply with for SMEs.”


European Federation of Associations of Health Product Manufacturers (EHPM) represents 2000 specialist health product manufacturers across Europe.

For more information contact EHPM by emailing [email protected], tel + 32 2 209 11 45, or visit

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